MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-13 for ANTI BACTERIA, POLLUTION AND DUST MASK N95 manufactured by Unk.
[183894774]
Ordered and received a so called n 95 mask from company stability pro - (b)(4) based. The product came in a cellophane bag without any label, precautions, instructions for use or other info regarding product or materials etc. Mask is clearly a counterfeit. Made of neoprene, fumes enough to cause cough. One paper mask liner and side filters holders without filters. Advertised product said would come with filters. Cost was (b)(6). They do not respond to email. No testing. Was not made available. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093768 |
| MDR Report Key | 9834913 |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-03-08 |
| Date Added to Maude | 2020-03-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANTI BACTERIA, POLLUTION AND DUST MASK N95 |
| Generic Name | RESPIRATOR, SURGICAL |
| Product Code | MSH |
| Date Received | 2020-03-13 |
| Device Expiration Date | 2020-03-08 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-13 |